CARDINAL Adjustable Annuloplasty Ring System For Treatment of Mitral Regurgitation

Mitral Valve Insufficiency Clinical Trial

Official title:

Valtech Cardinal Adjustable Semi-Rigid Annuloplasty Ring System For Treatment of Mitral Valve Regurgitation in Open Surgical Repair

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01137734
• Other study ID #: VC1-1
• Status: Completed
• Phase: N/A
• Start date: March 2010
• Est. completion date: January 2014

Study information

• Verified date: October 2021
• Source: Edwards Lifesciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Annuloplasty device for repair of mitral valve regurgitation with option to adjust device post implant off pump, to optimize correction of mitral regurgitation. Unlike conventional annuloplasty ring, the Cardinal system offers the clinician the opportunity to make adjustments after weaning from cardiopulmonary bypass. Adjustability is expected to reduce the number of patients leaving the operating room with residual regurgitation after mitral valve repair.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 2014
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patient is a candidate for mitral valve repair.

• Patient able and willing to return to the implant center for follow-up visits.

• Able and willing to give informed consent and follow protocol procedures.

Exclusion Criteria:

• Severe organic lesions with retraction of chordate tendineae, severly fibrotic and immobile leaflets, severely deformed subvalvular apparatus.

• Evolving endocarditis or active endocarditis in the last 3 months.

• Heavily calcified annulus or leaflets.

• Congenital malformation with limited valvular tissue

• Patient requires mitral valve replacement.

• Previously implanted prosthetic mitral valve or annuloplasty ring/band.

• Patient requires aortic or pulmonic valve replacement or repair.

• Patient is pregnant (urine HCG test result positive) or lactating.

• Patient has a major cardiac or non-cardiac disease, which in the investigator's experience produces an unacceptable surgical risk.

• Life expectancy of less than twelve months.

• Patient is participating in concomitant research studies of investigational products

Related Conditions & MeSH terms

• Mitral Valve Insufficiency

Intervention

Device:
• Adjustable Annuloplasty Ring with option to adjust off pump.
Annuloplasty device repair of mitral valve regurgitation with option to adjust device post implant off pump, to optimize correction of mitral regurgitation. Unlike conventional annuloplasty repair, the Cardinal system offers the clinician the opportunity to make adjustments after weaning from cardiopulmonary bypass. Adjustability is expected to reduce the number of patients leaving the operating room with residual regurgitation after mitral valve repair.
• Device: Adjustable Annuloplasty Ring (with option to adjust off-pump)
Evaluate the performance and safety of the investigational adjustable annuloplasty ring device for the treatment of mitral regurgitation, with option to adjust on and off-pump.

Locations

Country	Name	City	State
Belgium	Hugo Vanermen	Aalst
Italy	Hospital San Raffaele	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Edwards Lifesciences

Countries where clinical trial is conducted

Belgium,  Italy, 

References & Publications (4)

Czesla M, Götte J, Voth V, Doll N. Single-Center Experience With Adjustable Annuloplasty Ring in Degenerative Mitral Regurgitation. Innovations (Phila). 2015 Jul-Aug;10(4):248-51; discussion 251. doi: 10.1097/IMI.0000000000000186. — View Citation

Kolsut P, Juraszek A, Brzozowski P, Dabrowski M, Witkowski A, Rózanski J, Kusmierczyk M. Case report on successful 'bail out' aortic homograft implantation in a 81-year old woman with aortic ring rupture after double TAVI procedure. J Cardiothorac Surg. 2015 Mar 4;10:28. doi: 10.1186/s13019-015-0233-x. — View Citation

Maisano F, Falk V, Borger MA, Vanermen H, Alfieri O, Seeburger J, Jacobs S, Mack M, Mohr FW. Improving mitral valve coaptation with adjustable rings: outcomes from a European multicentre feasibility study with a new-generation adjustable annuloplasty ring system. Eur J Cardiothorac Surg. 2013 Nov;44(5):913-8. doi: 10.1093/ejcts/ezt128. Epub 2013 Mar 25. — View Citation

Si MS, Conte JV, Romano JC, Romano MA, Andersen ND, Gerdisch MW, Kupferschmid JP, Fiore AC, Bakhos M, Bonilla JJ, Burke JR, Rankin JS, Wei LM, Badhwar V, Turek JW. Unicuspid Aortic Valve Repair Using Geometric Ring Annuloplasty. Ann Thorac Surg. 2021 Apr;111(4):1359-1366. doi: 10.1016/j.athoracsur.2020.04.147. Epub 2020 Jun 30. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Subjects with Valtech Cardinal Mitral Heart Valve Device Technical Success	Technical success of the implantation of the Cardinal Ring defined as the ability to size the annulus, place the sutures on the ring, lower the ring onto the valve, adjust the ring to the required size and disconnect the adjustment tool.	Day of surgery
Primary	Percentage of Subjects with Successful Off Pump Adjustment of their Valtech Cardinal Mitral Annuloplasty Ring	The technical feasibility of "off cardiac bypass pump" adjustment during surgery, when required of the Valtech Cardinal Mitral Heart Valve Annuloplasty Ring.	Day of surgery
Primary	Subject's Mitral Valve Regurgitation (MR) Post-procedure as Compared to Baseline	The percentage of subjects that had a reduction of their pre-operative mitral regurgitation grade as compared to the mitral regurgitation grade at the end of the procedure with the Valtech Cardinal Mitral Heart Valve Annuloplasty Ring.	At the end of the procedure on the day of surgery compared to baseline.
Primary	Subject's Mitral Valve Regurgitation (MR) at Discharge as Compared to Baseline	The percentage of subjects that had a reduction of their pre-operative mitral regurgitation grade as compared to the mitral regurgitation grade at hospital discharge with the Valtech Cardinal Mitral Heart Valve Annuloplasty Ring.	Day of discharge compared to baseline.
Primary	Subject's Mitral Valve Regurgitation (MR) at 30 Days as Compared to Baseline	The percentage of subjects that had a reduction of their pre-operative mitral regurgitation grade as compared to the mitral regurgitation grade at 30 days with the Valtech Cardinal Mitral Heart Valve Annuloplasty Ring.	30 days compared to baseline.
Secondary	Subject's Device Related Adverse Event Rate	The percentage of subjects that had a device related adverse event with the Valtech Cardinal Mitral Heart Valve Annuloplasty Ring.	6 months